Engineer/Senior Engineer (Process Sciences)

Pharma Technical Operations, Cell & Gene Therapy (PTC) is the global team responsible for all CMC aspects of our cell and gene therapy portfolio, from development through scale-up and industrialization.  Our Philadelphia site specializes in gene therapy initiatives and will be actively involved in the construction of a new Gene Therapy Innovation Center aimed at delivering transformative gene therapies to patients.  

This role is a part of our Manufacturing Science and Technology (MSAT) team  which is responsible for supporting the development and manufacturing of gene therapies throughout the product lifecycle.  As a member of this team, you will collaborate closely with key stakeholders including Process Development, Manufacturing, Analytical, Quality, Supply Chain, and Regulatory Affairs, driving technical projects and laboratory experimentation to ensure successful clinical and commercial production. You will play an essential role in generating and reviewing critical documentation, executing wet-lab studies, and streamlining MSAT processes while fostering a culture of compliance and professional growth.

The Opportunity: 

As a Process Sciences Engineer/Senior Engineer, you will be responsible for supporting project lead activities for upstream and downstream drug substance manufacturing and executing laboratory experiments to drive these initiatives.  Additionally, you will:

• Generate and review key documents for Technology Transfer and validation, including Facility Fit Assessments, Risk Assessments, Manufacturing Batch Records, Process Validation Protocols and Reports, and Process Control Strategies

• Develop and maintain standard processes and procedures for MSAT related work

• Conduct root cause analysis for investigations and manage change processes for GMP manufacturing

• Monitor and provide technical guidance during production and studies at internal manufacturing sites and Contract Development and Manufacturing Organizations (CDMOs)

• Lead Technology Transfer sub-team meetings and support regulatory document preparation, interactions, and inspections

• Design, execute, and analyze process studies to support lifecycle deliverables and manufacturing improvements

• Manage laboratory activities including inventory, equipment handling, safety protocols, and staff training

Please note:  We offer the opportunity to join our team as either an Engineer or Senior Engineer, depending on your experience and qualifications.

Requirements for Engineer:

• You possess a Bachelor’s degree in a scientific or engineering discipline with 2 or more years of relevant experience in the biopharmaceutical industry

• You have a proven ability to design and execute experiments for process studies and manufacturing investigations, with demonstrated experience in cell culture bioreactors and/or purification

• You have a working knowledge of upstream and downstream bioprocessing principles, including cell culture, recovery, and purification in development and production environments

• You possess industry experience with GMP MSAT, including familiarity with GXP compliance

• You have demonstrated experience with root cause analysis, corrective action plan development and execution, and experience preparing contingency plans and logically working through technical issues to ensure  effective resolution

• You have adept skills in stakeholder management and thrive in a collaborative, matrixed environment

• You are able to travel up to 30% 

Requirements for Senior Engineer:

• You meet the qualifications for the Engineer level

• You possess at least 5 or more years of relevant experience in the biopharmaceutical industry 

• You possess demonstrated technical project management expertise to develop project goals, deliverables, and timelines

• You have experience supporting regulatory deliverables (including generation of regulatory documents and inspections) and operational improvement initiatives

• You have senior/lead experience representing your department in program level activities

Preferred Experience:

• Technology transfer or process validation experience

• Data analytic tools such as SAS JMP 

Relocation benefits are not approved for this posting.  

This is an on-site position; no remote options are available.

The expected salary range for this position based on the primary location of Philadelphia is $80,500 (min) - $115,000 (mid) - $149,500 (max) for the Engineer and $91,350 (min) - $130,500 (mid) - $169,650 (max) for the Senior Engineer.  Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.  A discretionary annual bonus may be available based on individual and Company performance.  This position also qualifies for the benefits detailed in this link.

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